U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jun 23, 2024

§ 1308.22 - Excluded substances.

The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

Excluded Nonnarcotic Products

Company Trade name NDC code Form Controlled substance (mg or mg/ml)
Aphena Pharma Solutions—New York, LLCNasal Decongestant Inhaler/Vapor InhalerINLevmetamfetamine (l-Desoxyephedrine)50.00
Bioline LaboratoriesTheophed00719-1945TBPhenobarbital8.00
Goldline LaboratoriesGuiaphed Elixir00182-1377ELPhenobarbital4.00
Goldline LaboratoriesTedrigen Tablets00182-0134TBPhenobarbital8.00
Hawthorne Products IncChoate's Leg FreezeLQChloral hydrate246.67
Parke-Davis & CoTedral00071-0230TBPhenobarbital8.00
Parke-Davis & CoTedral Elixir00071-0242EXPhenobarbital40.00
Parke-Davis & CoTedral S.A.00071-0231TBPhenobarbital8.00
Parke-Davis & CoTedral Suspension00071-0237SUPhenobarbital80.00
Parmed PharmacyAsma-Ese00349-2018TBPhenobarbital8.10
Procter & Gamble Co., TheVicks VapoInhaler37000-686-01INLevmetamfetamine (l-Desoxyephedrine)50.00
Rondex LabsAzma-Aids00367-3153TBPhenobarbital8.00
Smith Kline ConsumerBenzedrex49692-0928INPropylhexedrine250.00
Sterling Drug, IncBronkolixir00057-1004ELPhenobarbital0.80
Sterling Drug, IncBronkotabs00057-1005TBPhenobarbital8.00
White Hall LabsPrimatene (P-tablets)00573-2940TBPhenobarbital8.00
[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]